Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

Last updated: April 1, 2025
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

BAL-FAIOL IOL

Monofocal IOL

Cataract surgery

Clinical Study ID

NCT05317728
ILR286-E002
  • Ages > 22
  • All Genders

Study Summary

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Able to understand and sign an Institutional Review Board / International EthicsCommittee approved informed Consent form;

  • Willing and able to attend all scheduled study visits as required by the protocol;

  • Diagnosed with bilateral cataracts requiring removal by phacoemulsification with aclear corneal incision;

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • Subjects taking medications that may affect accommodation;

  • Clinically significant eye abnormalities as specified in the protocol;

  • Previous eye surgery as specified in the protocol;

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 175
Treatment Group(s): 3
Primary Treatment: BAL-FAIOL IOL
Phase:
Study Start date:
March 31, 2023
Estimated Completion Date:
December 31, 2026

Study Description

In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.

This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.

This study will be conducted in Central America.

Connect with a study center

  • Clinica 20/20

    San José,
    Costa Rica

    Site Not Available

  • Laser Center SA

    Santo Domingo, 10124
    Dominican Republic

    Completed

  • Centro de Retina Medica y Quirurgica SC

    Zapopan, Jalisco 45116
    Mexico

    Site Not Available

  • Asociación Para Evitar la Ceguera en México

    Mexico City, 04030
    Mexico

    Site Not Available

  • Salauno Salud SAPI de CV

    Mexico City, 06600
    Mexico

    Site Not Available

  • Panama Eye Center

    Panama,
    Panama

    Active - Recruiting

  • Alcon Investigator 8165

    Panamá,
    Panama

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.